(160 days)
The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains its loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.
The provided text describes a 510(k) submission for the Benvenue VCF Osteo Coil System, a surgical instrument. It details the device, its intended use, and claims of substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets them.
The "Discussion of Nonclinical Tests" section states: "The safety and performance of the Benvenue VCF Osteo Coil System have been substantiated through extensive non-clinical testing. Results of testing show that the Benvenue VCF Osteo Coil System can reliably and safely perform as intended in the treatment of pathological compression fractures of the vertebral body, by creating channels within the existing spinal bone structure in preparation for the flow of polymethylmethacrylate bone cement (PMMA). No new questions of safety or effectiveness have been raised."
This statement is a high-level summary and does not provide the specific details required to answer the request, such as a table of acceptance criteria, reported performance, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.
Therefore, I cannot provide the requested information from the given text. The text confirms that non-clinical tests were performed to substantiate safety and performance, but it does not describe these tests or their results in sufficient detail to fulfill your requirements.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.